Xeloda-Capecitabine

WARNING
If you are taking capecitabine and warfarin (Coumadin?), a blood thinning drug, it is important to tell your doctor or healthcare provider. Your doctor will need to monitor your INR or prothrombin time (PT) frequently. Capecitabine can increase the effect of warfarin which can lead to increased risk of bleeding. Patients older than 60 years and those with cancer may have a greater risk of bleeding.
Uses For This Medication

Capecitabine is used alone or together with other chemotherapy medications to treat colon or rectal cancer (colorectal cancer) or breast cancer.

Capecitabine is being studied for the treatment of other cancers, including ovarian cancer, lung cancer, and pancreatic cancer.

This medication may also be given for other conditions as determined by your doctor.

How This Medication Works

Capecitabine is changed in the body into the substance 5-fluorouracil (5-FU). 5-FU is a chemotherapy medication that doesn’t allow cancer cells, also known as tumor cells, to divide and grow normally, which leads to tumor cell death.

Benefits of This Medication

In patients with metastatic breast cancer, capecitabine in combination with docetaxel may lengthen how long a person lives by several months. In patients with colorectal cancer, capecitabine may be used in a couple of different ways. Capecitabine can be used as an additional therapy after surgery for patients with colorectal cancer which is in the early stages. This is known as adjuvant therapy. In patients who have metastatic colorectal cancer, capecitabine alone may cause the tumor to shrink or disappear. When capecitabine is given in combination with oxaliplatin, another chemotherapy medication used to treat colorectal cancer, it may lengthen how long a person lives by several months.

Who Should Not Take This Medication

You should not take this medication if you:

Are allergic to capecitabine, to any of its components, or to 5-FU

Lack the enzyme dihydropyrimidine dehydrogenase (DPD)

Have serious kidney problems

Precautions to be Aware of Before Taking This Medication

Gastrointestinal related precautions

This medication may cause diarrhea, which can lead to dehydration. If diarrhea occurs, contact your doctor or healthcare provider. Drink plenty of water and fluids that contain electrolytes (e.g. Gatorade, Pedialyte) to avoid dehydration.

This medication may cause redness or sores in your mouth, throat or on your lips. Talk with your doctor or healthcare provider about proper mouth and throat care (for example brushing and flossing). Avoid foods and drinks that may irritate your mouth such as citrus fruits and juices, tobacco, and spicy foods. Using a salt and baking soda mouthwash (1 teaspoon salt & 1 teaspoon baking soda dissolved in 1 quart of water) four times a day may be soothing.

Organ related precautions

Rarely, this medication can cause changes in the ability of your liver and/or kidneys to work normally. Your doctor or healthcare provider will check your liver and kidneys regularly, usually through blood tests, while you are on this medication to make sure that they are both working properly. If you have any liver or kidney problems before starting this medication, make sure that you tell your doctor or healthcare provider so that he or she can watch you carefully for possible problems or side effects.

This medication is cleared from the body by the kidneys. In patients with severe kidney problems, capecitabine may not be cleared from the body as well. This can lead to high levels of this medication in the body and a greater chance of side effects. If you have any kidney problems before starting this medication, make sure that you tell your doctor or healthcare provider so that he or she can watch you carefully for possible problems or side effects.

Rarely, this medication can cause heart related problems. Patients with existing heart conditions such as coronary artery disease may be more likely to have heart related side effects.

Blood related precautions

This medication may temporarily reduce the number of germ fighting white blood cells in your blood. This can increase your risk of infection. Contact your doctor or healthcare provider promptly if you develop any signs of an infection such as fever, painful urination, chills, or a sore throat that doesn’t go away. If your white blood cell levels become too low, your doctor or healthcare provider may recommend that your treatment be delayed and/or you receive medication to increase the number of white cells in your blood. To lower your risk of infection, stay away from crowds and people with colds or other illnesses, wash your hands with soap and water well and often, and brush and floss your teeth daily.

This medication may temporarily lower the number of red cells in your blood. This can increase your risk of anemia. If your red blood cell level becomes low, you may feel tired and weak. If your red blood cell level becomes too low, your doctor or healthcare provider may recommend that your treatment be delayed, that you receive a red blood cell transfusion, and/or you receive a medication to help increase the red cells in your blood.

This medication may temporarily reduce the number of platelets in your blood. This can increase your risk of bleeding. Contact your doctor or healthcare provider if you notice unusual bleeding or bruising, have black or tar-like stools, see blood in your urine, or develop pinpoint red spots on your skin. If your platelet levels become too low, your doctor or healthcare provider may recommend that your treatment be delayed, that you receive a platelet transfusion, and/or that you take medication to help increase the number of platelets in your blood. To lower your chance of bleeding, do not use aspirin, aspirin-containing medications, or aspirin-like medications (for example ibuprofen, naproxen). Use caution with sharp objects like razors and nail cutters, and avoid activities that can cause cuts, bumps, and bruises.

Miscellaneous precautions

If you lack the enzyme dihydropyrimidine dehydrogenase (DPD), you may be more likely to have serious side effects from this medication, including swelling and sores in the mouth, diarrhea, low white blood cell levels, or nerve damage which can cause problems with the normal activity of the nervous system (symptoms include limb weakness or numbness, loss of memory and/or vision, confusion, headache, behavior problems, sexual dysfunction).

This medication can cause hand-and-foot syndrome. This condition can cause the hands or soles of the feet to tingle, become numb, painful, swollen or red. Contact your doctor or healthcare provider if you experience new symptoms, if your symptoms become painful or worsen, or if you are unable to perform routine daily activities as a result of this condition. If you do develop this condition, you should try to protect your feet and hands. Prevent injuring them and avoid prolonged heat (for example taking hot baths) or pressure (for example wearing tight-fitting shoes). In addition, rubbing petroleum jelly (Vaseline or a similar type cream or ointment) on your hands and feet at bedtime and covering them with cotton gloves and/or socks may be helpful.

Do not receive any immunizations (vaccinations) while on this medication without your doctor or healthcare provider’s approval. This medication can increase your risk of infection. For certain immunizations, you may develop the infection that the immunization is intended to prevent.

Patient specific precautions

It is not known if this medication is safe and effective in children.

Older patients (80 years of age or older) may be more likely to have a greater incidence of
gastrointestinal problems. Patients 60-79 years of age have a similar incidence of gastrointestinal problems as the general population.

Pregnancy and breastfeeding precautions

This medication may cause fetal harm. When taking this medication, you should use effective birth control to prevent pregnancy. Tell your doctor or healthcare provider right away if you or your spouse/partner becomes pregnant.

It is not known whether this medication is found or excreted in breast milk. Since many medications are excreted in breast milk and because this medication can cause serious harmful reactions in infants, breastfeeding should be avoided.

Many anti-cancer therapies can cause sterility. Notify your doctor or healthcare provider if you want to have children in the future.

Medication and Food Interactions

Before using this medication, tell your doctor or healthcare provider of all prescription or over-the- counter products you are taking, including dietary supplements or vitamins, herbal medicines and homeopathic remedies. Do not start or stop any medication without your doctor or healthcare provider’s approval.
Possible interactions can occur with capecitabine and the following medications:

Antacids (such as Maalox?)

Phenytoin (Dilantin?)

Warfarin (Coumadin?) (see Warning)

Leucovorin

Folic acid

NOTE: This list may not include all medications that can have interactions with arsenic trioxide.

Side Effects

All medications can cause side effects. However, not all patients will experience these side effects. In addition, other side effects not listed can also occur in some patients. You should call your doctor or healthcare provider if you have any questions or concerns while you are on this medication.

You should contact your doctor or healthcare provider if you experience any side effect(s) which don’t go away, worsen, are serious in nature, or are worrisome to you.

Side effects can occur when capecitabine is given alone or together with other chemotherapy medications. The side effects listed below are those reported in patients who were treated with capecitabine alone.

More common side effects

Tiredness, weakness

Diarrhea, nausea, vomiting, sores in mouth or on lips, abdominal pain, loss of appetite (see
Precautions To Be Aware Of Before Taking This Medication)

Hand-and-foot syndrome (see Precautions To Be Aware Of Before Taking This Medication)

Rare side effects

This is not a complete list of the rare side effects reported with capecitabine. For a complete list, please talk with your doctor or healthcare provider about reviewing a copy of the package insert.

Bleeding in the stomach

Kidney problems (see Precautions To Be Aware Of Before Taking This Medication)

Liver problems (see Precautions To Be Aware Of Before Taking This Medication)

Changes in blood pressure, heart rhythm abnormalities

Blood clots in the lungs

Stroke

Allergic reaction

How To Take This Medication

This medication is taken by mouth (orally) with water within 30 minutes after the end of a meal. Take this medication exactly as directed by your doctor or healthcare provider. If you do not understand these instructions, ask your doctor or healthcare provider to explain them to you. This medication can be given in different doses depending on your weight and the type of condition being treated.

It is important that you only use this medication when it’s been prescribed for you. Sharing this medication with someone for whom it is not prescribed could cause harm.

There are two different strengths of capecitabine – and your doctor or healthcare provider may want you to take a combination of tablet strengths. If a combination of tablets is prescribed, you must correctly identify the tablets. Taking the wrong combination of tablets could cause an overdose or underdose. The 150mg tablets are light peach in color and have a “150” engraved on one side. The 500mg tablets are peach in color and have “500” engraved on one side.

If you miss a dose of capecitabine, DO NOT take the missed dose and DO NOT double up on the next dose. Skip the missed dose and notify your doctor.

If you accidentally take too many pills or someone else accidentally takes your medication, contact your doctor, your local poison control center at 1-800-222-1222, or emergency services immediately.

Proper Storage

Store this medication at room temperature and keep in its original container.

Keep this medication out of the reach of children or pets.

Ask your doctor or healthcare provider how to dispose of any medication that you no longer use.